The innovative therapy involves injecting 10 million stem cells directly into the spinal cord during surgery to stabilize the spine after a severe injury. The cells are made from embryonic stem cells which are then converted into a class of stem cells found in the brain and spinal cord that serve to bolster healthy functioning of nerve cells. The treatment is manufactured by Fremont, Calif.-based Asterias Biotherapeutics. Six patients were enrolled in the clinical trial.

“With these patients, we are seeing what we believe are meaningful improvements in their ability to use their arms, hands and fingers at six months and nine months following AST-OPC1 administration,” said Richard G. Fessler, MD, PhD, professor in the department of neurosurgery at Rush University Medical Center in Chicago and lead investigator study.

Rush is one of six centers around the country participating in the trial.

In April 2016, a physician team at Keck Medical Center of the University of Southern California in Los Angeles — another site participating in the trial — performed the treatment on 21-year-old Kris Boesen. The university issued a release on Kris’ progress in September 2016.

“As of 90 days post-treatment, Kris has gained significant improvement in his motor function, up to two spinal cord levels,” said Charles Liu, MD, PhD, director of the USC Neurorestoration Center who led the team and injected the 10 million stem cell dose into the patient’s spine. “In Kris’ case, two spinal cord levels means the difference between using your hands to brush your teeth, operate a computer or do other things you wouldn’t otherwise be able to do, so having this level of functional independence cannot be overstated.”

Asterias Biotherapeutics expects to discuss the regulatory path forward for the treatment with the Food and Drug Administration in mid-2017.

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